FDA warns marketer of unapproved products claiming to treat serious health conditions
The Food and Drug Administration has posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.
“Today, we posted a warning letter to a company preying on patients who may be seeking alternative treatments for chronic pain, cancers, arthritis and autoimmune and neurological disorders,” said FDA Commissioner Scott Gottlieb, M.D., in a statement released yesterday. “These patients deserve proven treatments not false promises that can deter them from seeking otherwise effective care, and that can also contain ingredients or contaminations that can threaten their health.
The FDA issued a warning letter to Nutra Pharma for their products: “Nyloxin Oral Spray,” “Nyloxin Topical Gel,” “Nyloxin Topical Roll-On,” “Nyloxin Topical Roll-On ES,” “Nyloxin Professional Size Pump Topical Gel” and “Regular Strength Sample Pack.” These products also may confuse consumers because its name is similar to FDA-approved drugs.
Examples of claims made include:
- “Nyloxin . . . treats conditions that cause chronic pain.”
- “[C]obra venom saw its primary use in the treatment of cancer and arthritis. Reportedly the venom was used to treat liver cancer, lung cancer, esophageal cancer, skin cancer, and leukemia.”
- “Today, cobra venom is being studied for treating various forms of pain, cancers, autoimmune and neurological disorders.”
- “Researchers in China are examining the possibility that cobra venom can be used to treat drug addiction.”
- “Treatment of the Cobrotoxin in 90 cases with heroin dependence.”
The FDA has requested responses from Nutra Pharma within 15 working days. The warning letter also states that failure to correct violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Healthcare professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program.
